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Background and importance Fampridine (4-aminopyridine) is a drug whose indication is to improve gait in adult patients with multiple sclerosis with walking disability (EDSS 4–7). It is important to describe adverse effects that occur in certain patients in order to prevent them in the future. Aim and objectives To describe two cases of atrial fibrillation in patients who were being treated with fampridine and its possible relationship. Material and methods This was a case evaluation of two patients, aged 68 and 74 years, diagnosed with progressive secondary multiple sclerosis, recently receiving treatment with fampridine at a dose of 10 mg every 12 hours. Both patients presented with arterial hypertension and took angiotensin converting enzyme inhibitors. They were referred to the emergency department after arrhythmic cardiorespiratory auscultation and generalised weakness. The following constants were measured to confirm the pathology: systolic arterial blood pressure (SABP), diastolic blood pressure (DBP), temperature (Ta), oxygen saturation (SaO) and heart rate (HR). In addition, an ECG and a complete analysis were performed. The degree of drug/adverse reaction causality was evaluated using the Naranjo algorithm. Results Both patients remained in the emergency area until the results of the examination were obtained. The mean results of the constant measurements were: SABP=140 mm Hg, DBP=85 mm Hg, Ta=36°C, SaO=95% and HR=105 beats/min. There were no signs of ischaemia and/or blockages on the ECG in either of the cases, the haemogram was normalised for age and biochemistry was not altered. Once the constants within the range had been established, they were discharged from hospital. In both cases, oral anticoagulants (acenocumarol) were prescribed, and in one case digoxin (0.5 mg/day), with the consequent suspension of fampridine. Naranjo’s algorithm established the causality relationship as ‘probable’ (score of 5). The regional pharmacovigilance centre was notified by yellow card. Conclusion and relevance The fampridine data sheet describes tachycardia as a rare adverse effect but does not describe atrial fibrillation. In our patients, there was the previous existence of arterial hypertension. Therefore, we consider it important to monitor hypertension and heart rate in patients treated with this drug. The need to notify the pharmacovigilance centre by means of the yellow sheet should also be noted. References and/or acknowledgements No conflict of interest. |